Sonic and Ultrasonic Methods and Apparatus for Treatment of Glaucoma

ABSTRACT

Disclosed are methods and apparatus, including eyewear and a contact lens, for delivering sound energy to an eye, comprising two or more sonic or ultrasonic transducers that emit sound energy, wherein each transducer is (i) operably linked to a power source and (b) capable of emitting sound energy at more than one frequency and for a variable time period; and a positioning mechanism to position the transducers at an exterior surface of an eye so as to deliver sound energy to an internal part of the eye, for example the Schlemm&#39;s canal or trabecular meshwork.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/272,970 filed Sep. 22, 2016, which claims the benefit under 35 U.S.C.§ 119(e) to U.S. Provisional Application No. 62/222,999, filed Sep. 24,2015, all of which are herein incorporated by reference in theirentirety.

FIELD OF THE DISCLOSURE

Disclosed are devices for non-invasive delivery of sonic and ultrasonicenergy to an eye, and methods of using such devices for the treatment ofglaucoma.

BACKGROUND OF THE DISCLOSURE

Glaucoma is the leading cause of irreversible blindness and the secondleading cause of blindness in the world. There are 67 million peopleaffected by glaucoma worldwide (10% suffer complete blindness),projected to increase to 80 million by 2020. Three percent of the globalpopulation over 40 years old, and 1 in 10 over the age of 80, hasglaucoma. In the United States, 2.2 million people have chronic openangle glaucoma (COAG), projected to increase to 3.4 million by 2020.(Quigley H A, Br J Ophthalmol, 1996; Friedman D S, et al., ArchOphthalmol, 2004)

The glaucoma medication market is expected to rise from $2.4 billion in2013 to $3 billion by 2023 across the major markets of the UnitedStates, France, Germany, Italy, Spain, the United Kingdom and Japan.Medication sales are expected to increase from $1.7 billion in 2013 to$2.2 billion by 2023.

Types of glaucoma include open and closed angle glaucoma, pigmentaryglaucoma and exfoliation glaucoma. In most types of glaucoma, blindnessis a result of damage to the optic nerve caused by increased fluidpressure inside of the eye, or increased intraocular pressure (IOP). Thetrabecular meshwork (TM) is series of cellular filters, admitting fluidfrom the anterior eye into its primary drain, the Schlemm's canal. Thismeshwork has three layers of cells, each with apertures that areprogressively smaller. Primary resistance to fluid outflow is at thejuxtacanalicular TM and the inner wall of the Schlemm's canal. While theTM does a very good job of keeping pigment and cellular debris out ofthe Schlemm's canal, and vessels that drain the Schlemm's canal into thebody's lymphatic system, the TM is vulnerable to clogging by cellulardebris consisting primarily of melanocytes, melanin granules, and otherdebris from the iris and the interior of the eye. The uveal meshwork isthe first and coarsest meshwork to guard this drain and has the widestapertures for fluid and debris to pass through, but in the case of manyadvanced glaucoma patients even this becomes completely clogged by anagglomeration of waste and dead cells.

There is currently no cure for glaucoma. Medical treatments are directedat decreasing intraocular pressure on an ongoing basis as needed tolimit or slow the progression of damage to the optic nerve and preservethe patient's vision. Current glaucoma medications face several barriersto patient compliance including cost, side effects, difficultadministration, comorbid eye disease, patient age, education or income,frequency of dosing, and multiple medications. Early clinicalintervention for glaucoma includes topical pharmaceutical agents (suchas medicated eye drops) and laser treatment. Intraocular surgicalprocedures, such as filtering surgery trabeculectomy and tube implantsurgery, are available but generally reserved for patients for whomtopical medications and laser treatment have not been successful.Topical medications such as eye drops are expensive, must be frequentlydosed and are difficult to administer resulting in poor compliance. Manynew surgeries are being developed to lower intraocular pressure inglaucoma patients, including microinvasive glaucoma surgery (MIGS) suchas iStent, trabectome, endocyclophotocoagulation, hydrus microstent,cypass (suprachoroidal) and xen implant (anterior chamber), however, anyinvasive procedure will carry risks of infection, pain, scarring andother adverse complications.

There have been attempts to design non-invasive devices that deliverultrasonic energy to the eye to lower intraocular pressure in glaucomapatients. For example, United States Patent Application Publication Nos.US 2014/0364780, US 2011/0087138, US 2013/0211395 and US 2008/0051681disclose methods for reducing intraocular pressure using devices thatemit ultrasonic energy at the surface of the eye to oscillate thetrabecular meshwork or Schlemm's canal. However, the disclosed devicesare hand-held devices that are placed in contact with the surface of theeye. Hand-held devices lack the accuracy needed to repeatedly administerultrasonic energy to the precise location at the surface of the eye.Also, a clinician would need to be involved to hold the device at thecorrect location and angle, thus increasing the cost of treatment.Furthermore, the disclosed devices comprise a single transducer thatdoes not permit the delivery of a combination of frequencies or thedelivery of frequencies in formats that would minimize tissue damage,such as phased array. United States Patent Application Publication Nos.US 2014/0364780, US 2011/0087138, US 2013/0211395 and US 2008/0051681are incorporated by reference herein in their entireties.

In short, there is a need for non-invasive methods and devices toeffectively administer glaucoma treatments that do not damage the tissueof the eye, and that can be accurately performed on a repeated basis asneeded to decrease intraocular pressure in a patient's eye, andpreferably, with minimal supervision by a clinician.

BRIEF SUMMARY

Disclosed herein is an apparatus for delivering sound energy to an eye,comprising: (a) two or more transducers that emit sound energy and areoperably linked to a power source, wherein each transducer isindependently capable of emitting sound energy at more than onefrequency and for a variable time period; and (b) a positioningmechanism to position the transducers at an exterior surface of an eyeso as to deliver the sound energy to an internal part of the eye.

Also disclosed herein is an eyewear apparatus for delivering soundenergy to an eye, comprising: (a) two or more sound transducers operablylinked to a power source, mounted directly or indirectly to an eyewear,that emit sound energy, wherein each transducer is capable of emittingsound energy at more than one frequency and for a variable time period;and (b) a positioning mechanism, mounted directly or indirectly to theeyewear apparatus, to position the transducers at an exterior surface ofan eye so as to deliver the sound energy to an internal part of the eye.In some embodiments, the eyewear apparatus is selected from the groupconsisting of: glasses, goggles, a helmet, and a visor.

Also disclosed herein is a contact lens for delivering sound energy toan eye, comprising: two or more sound transducers that emit sound energyand are operably linked to a power source, wherein each transducer isintegrated into the contact lens and independently capable of emittingsound energy at more than one frequency and for a variable time period,wherein the transducers are positioned at the corneal surface of the eyeso as to deliver the sound energy to a desired internal part of the eye.In some embodiments, the contact lens consists of from 4 to 24transducers.

In some embodiments, the sound energy comprises sonic frequencies, forexample, high sonic frequencies, or ultrasonic frequencies, for examplelow or high ultrasonic frequencies. In some embodiments, the soundenergy is selected from a frequency consisting of: from about 20kilohertz to about 200 kilohertz, about 5 kilohertz to about 200kilohertz, about 5 kilohertz to about 50 kilohertz, and about 5kilohertz to about 25 kilohertz.

In some embodiments, the variable time period is selected from the groupconsisting of: about 0.1 second, about 0.5 seconds, about 1 second,about 2 seconds, about 5 seconds, about 10 seconds, about 15 seconds,about 20 seconds, about 25 seconds, and about 30 seconds.

In some embodiments, the transducers emit sound energy in a phased arrayformat. In some embodiments, the transducers are positioned on a ring oron a rotor.

In some embodiments, the positioning mechanism is selected from thegroup consisting of: self-adjustable, manually adjustable,electronically adjustable, and any combination thereof In someembodiments, the positioning mechanism comprises a multiple-axissuspension system. In some embodiments, the positioning mechanismcomprises a 3- or 4-axis gimbal mount.

In some embodiments, the internal part of the eye is selected from thegroup consisting of: the Schlemm's canal, trabecular meshwork, and boththe Schlemm's canal and trabecular meshwork. In some embodiments, theinternal part of the eye is an area surrounding the Schlemm's canal orthe trabecular network. In some embodiments, the exterior surface of theeye is the cornea. In some embodiments, the sound energy is deliveredaxially or radially at the exterior surface of the eye.

In some embodiments, the apparatus is operably linked to a computerinterface.

BRIEF DESCRIPTION OF THE DRAWINGS

The subject matter that is regarded as the invention is particularlypointed out and distinctly claimed in the claims at the conclusion ofthe specification. The foregoing and other objects, features, andadvantages of the invention will be apparent from the following detaileddescription taken in conjunction with the accompanying drawings.

FIG. 1 illustrates in schematic section view, an embodiment of atwo-transducer array applying cavitation energy to an area above theSchlemm's canal and trabecular meshwork.

FIGS. 2A-2C illustrate an embodiment of a transducer array over theindocorneal angle in close-up section (A), the positioning of the arrayover the junction of cornea and sclera (B), and feedback from thetransducer array as it may appear on the system monitor (C).

FIGS. 3A-3B shows an embodiment of a transducer array positioned overthe indocorneal angle, with design adjusted in angle to match theexterior junction of cornea and sclera, with two transducers visible(A), and a close-up of a configuration with three transducers (B).

FIGS. 4A-4B illustrate an anterior view of the eye where topical axialstimulation is applied to the front of the cornea (A), or over thecorneal angle (B).

FIGS. 5A-5B show variations of simultaneous corneal angle and topicalaxial transducer stimulation, a sectional view with anterior eye anatomy(A), and an anterior view schematic (B).

FIG. 6 shows a close-up schematic of the frequency product over an areaof Schlemm's canal and the trabecular meshwork.

FIGS. 7A-7B illustrate embodiments of a transducer array ring, hereshown in side-view schematic of a glaucoma glasses system (A), and arear-view schematic of the transducer array ring (B), demonstrating howalternating pairs of transducers are energized around the eye.

FIGS. 8A-8E illustrate embodiments of micro-machined ocular transducerarrays, rings for placement over the corneal limbus (A), fractionalcircumference arrays for use over portions of the corneal limbus (B),axial focused beam arrays for topical corneal use (C), a section of afresnel array from with couplant slots (D), and an oblique view withcouplant slots (E).

FIGS. 9A-9C illustrate embodiments of micro-machined transducer arrays,with a fresnel design (A), a semi-circular arrangement of such rings andthe resulting wave product (B), each ring receiving one of seven phasedsignals (C) so as to produce a single focused wave-form.

FIGS. 10A-10C depict the manner in which waves propagate, in particularhow beams reinforce at nodal intersections (A), how phase and frequencymodulation may be used to shift focus of target area by manipulatingsignal from one transducer (B), and how tsunami waves from a topicalaxial transducer decrease in wavelength and increase in amplitude at theshallower depths of the anterior eye (C).

FIGS. 11A-11C illustrate an exploded oblique schematic view of anembodiment of the in-clinic device (A), axis of adjustment for thegimbal mount (B), and a schematic of the patient head positioned withthe rotor in-line with the patient eye (C).

FIG. 12A-12C illustrate an embodiment of the phased transducer arrayrotor, in oblique side exploded view showing position adjustments andphysician optics (A), rear view with an attached couplant skirt (B), andin schematic positioned at front of eye (C).

FIGS. 13A-13B shows an embodiment of glaucoma glasses in side viewschematic with a radial transducer array ring with and topical axialtransducer at the front of the cornea (A), and as the device sits on thepatient head (B).

FIG. 14 shows a left-eye anterior schematic of an embodiment of thetransducer array ring within the frame of the glaucoma glasses device.

FIGS. 15A-15B illustrate a close-up oblique view of an exemplaryglaucoma glasses transducer array (A), prior to being located againstthe surface of the patient eye (B), in oblique cutaway schematic.

FIGS. 16A-16D show micro-electronic contact lenses known in the art. TheSENSIMED Triggerfish® Sensor (SENSIMED/AG) (A) is a soft disposablesilicone contact lens embedding a micro-sensor that captures spontaneouscircumferential changes at the corneoscleral area. The Samsung GearBlink™ (SAMSUNG INC.) Smart Contact Lens (B) has a display that canproject images straight into the user's eye. The lenses are equippedwith a built-in camera and sensors that can be controlled by blinking.Embedded antennas send content to a smartphone where the data isprocessed. Bionic contact lenses (C) are being developed to provide avirtual display that could have a variety of uses from assisting thevisually impaired to the video game industry. The device will have theform of a conventional contact lens with added bionics technology in theform of augmented reality, with functional electronic circuits andinfrared lights to create a virtual display. Novartis AG and Google Inc.are joining forces to work on a smart contact lens that monitorsblood-sugar levels and corrects vision (D).

FIGS. 17A-17C show a rear view schematic of an embodiment of thetransparent battery contact lens transducer array (A), a rear-viewoblique appearance (B), and (C) a schematic of the resultingwave-pattern (C).

FIGS. 18A-18B show a sectional depiction of an embodiment of atransparent battery contact lens against the surface of the patient eyein oblique schematic (A), and the phased function of the transducertension ring in promoting suction and positive grip to the patient eyewhile being energized (B).

FIGS. 19A-19B illustrate an exploded rear view of each layer of anembodiment of a transparent battery glaucoma contact lens transducer(A), and a side view sectional schematic of the layers assembled (B).

FIGS. 20A-20B show an embodiment of a transparent battery contact lenstransducer array in exploded layer view from the rear (A), and sectionsof each layer from the side (B).

FIGS. 21A-21B show an exploded rear view of the layers of an embodimentof the wireless power transfer (WPT) contact lens transducer array (A)and exploded section side-view (B).

FIGS. 22A-22B illustrate two exemplary methods of powering the WPTcontact lens, through electric induction (A) and by laser beam (B) usingthe wireless power transfer glasses device.

FIGS. 23A-23F illustrate a sequence by which an embodiment of the laserWPT glasses transfers power to the transparent battery contact lensdevice: depending upon the location of the eye (A) the contact lenseither confirms a ‘safe’ response based a test pulse from the laser (B),the lens confirms with immediate feedback (C) or not, and if so, output(D) is made at a time when safe to the eye. Panel (E) illustrates inschematic test and full levels of the laser as well as the RF orinfrared feedback system. Panel (F) depicts the relative size andcomplexity of the charging glasses, with a battery pack worn on theperson of the patient.

FIG. 24 illustrates an embodiment of the handheld transducer array unitwith three transducer array attachments and cutaway of a suspensionsystem.

FIG. 25 depicts an embodiment of the handheld transducer array attachedto the lower cost gimbal mounting device to deliver more preciseprograms of treatment than with the same system handheld.

FIGS. 26A-26C depict close-ups of an embodiment of an array attachmentfor the handheld transducer array (A), two forms of suspension (B), andwave intersections resulting from such a configuration (C).

FIGS. 27A-27B depict an embodiment of the sonic frequency glaucomaglasses in side-view schematic with the location and suspension of a HFSonic Transducer against the eyelid (A), and as the device appearsinstalled on patient head (B).

FIG. 28 depicts a top-view schematic of an embodiment of the sonicfrequency glaucoma glasses.

DETAILED DESCRIPTION

Glaucoma is progressive optic neuropathy characterized by loss ofretinal ganglion cells resulting in visual field (VF) loss. The primarycause of glaucomatous nerve damage is a build-up in intraocular pressure(TOP) of fluid in the anterior chamber of the eye. The pressure buildsbecause the eye produces fluid more quickly than it can drain throughthe trabecular meshwork (TM) and Schlemm's canal. In most cases, this isdue to a fouling of the TM, otherwise an effective filter and pressuremaintenance system for fluid leaving the eye. The non-invasive methodsand devices described herein are based on the use of ultrasonic or sonicvibrations to loosen the meshwork, destroy debris clogging the TM,promote outflow to of intraocular fluid to the Schlemm's canal and lowerintraocular pressure.

FIG. 1 illustrates in schematic section view, an embodiment of atwo-transducer array applying cavitation energy at an intocorneal angleto an area above the Schlemm's canal and trabecular meshwork. Sonic andultrasonic waves from the transducers travel through the corneal limbusto target precise locations in the interior of the eye. The energy beamsare targeted to a precise location to form cavitation bubbles in theSchlemm's canal and the TM. Energy levels, direction, frequency andphase are adjusted for maximum cavitation at the boundary of theSchlemm's canal and TM. Individual beam energies attenuate to a harmlesslevel. Overlapping nodes cavitate fluids and clean the TM. Waveamplitudes are adjusted to target fluid in the Schlemm's canal. Heatbeneath the transducers is mitigated, while phase and frequencymodulation shifts the location of wave hot spots.

FIG. 2 illustrates a method to prevent cavitation of the tear layer ofthe eye or burning of corneal cells using a single transducer array.FIG. 2A shows the anatomy of the indocorneal angle in close-up sectionwith arrows showing the direction of fluid flow in the eye. FIG. 2Billustrates the positioning of two adjustable phased array multipletransducers over the junction of the cornea and sclera and providingstimulation at the indocorneal angle. Lower wattage from two or moresources reduces the risk of injury to the eye. Phase adjustment ensuresthat cavitation is distributed evenly through the targeted area andrefraction combines power in precisely defined areas. FIG. 2C showsechoes from the phased array and feedback from the transducer array asit may appear on an operably linked system monitor.

FIG. 3 shows an embodiment of a transducer array with two transducerspositioned over the indocorneal angle, with design adjusted in angle tomatch the exterior junction of cornea and sclera (or corneal sclera),with two transducers illustrated. Couplant is introduced at the surfaceof the eye where the transducers are placed. Interior structures of theeye are also shown (Schlemm's canal, ciliary muscle, TM, and iris). FIG.3B shows a close-up of a transducer array configuration with threetransducers illustrating that matching the exterior angle junction ispreferred and may be necessary when using the highest frequency rangesof ultrasonic stimulation. For rotating transducer arrays it may not benecessary to consider the exterior angle junction because in someembodiments, couplant, or the pliability of the eye surface may minimizethe need for such design adjustments, however for higher frequencycavitation, particularly where the desired energy is to propagatethrough the cornea as well as the sclera, an angle-adjusted transducerarray may be preferred.

FIG. 4 illustrates an anterior view of the eye where topical axialstimulation is applied to the eye at various positions in relation tothe corneal limbus, pupil and iris. In FIG. 4A, the transducer is placedat the front and center of the cornea (corneal angle) front In FIG. 4B,a transducer array is placed over the corneal limbus (topical axial).Transducers and waves produced by the transducers are also depicted.

FIG. 5 shows variations of simultaneous corneal angle and topical axialtransducer stimulation, a sectional view with anterior eye anatomy (FIG.5A), and an anterior view schematic (FIG. 5B). A single transducerapplies topical high frequency (HF) ultrasound energy and cavitationcleans the TM and Schlemm's canal. Topical low frequency (LF)stimulation promotes phagocytosis. When the transducer is applied to thefront of the cornea, tsunami waves transport energy to the circumferenceof the TM and Schlemm's canal. Phased array corneal stimulationinterference patterns from multiple transducers direct energy toparticular positions of the TM and Schlemm's canal. Topical axialstimulation propagates LF energies, which includes high sonicfrequencies (HSF) around the full circumference of the TM, primarily inorder to ‘clear’ debris broken up or dislodged by ultrasonicwavelengths. Except where noted the designations HF and LF refer toultrasonic energies. Sonic wavelengths will have some positive affect,particularly in the mid and upper ranges (see Example 7).

FIG. 6 shows a close-up schematic of the frequency product over an areaof Schlemm's canal and the trabecular meshwork. A three-transducer arraywith couplant feeds is illustrated with the following three transducers:a frequency modulated LF transducer, a frequency modulated HF transducerand a phase modulated ±90° transducer. All of the transducers may beamplitude modulated. Low frequency tsunami waves from the topical axialarray are shown around the Schlemm's canal and TM. The target area ofhighest energy is also shown.

FIG. 7 illustrates embodiments of a transducer array ring withsuspension, here shown in side-view schematic of a glaucoma glassessystem (FIG. 7A, also see Example 2), and a rear-view schematic of thetransducer array ring (FIG. 7B), demonstrating how alternating pairs oftransducers are energized around the eye. The suspension system andtransducer selector circuit allow for customization of the position ofthe phased array ring via a three-axis adjustment and adjustment of thecurrent (AC) applied to the transducers. The phased array ring ispositioned between HF damping/decoupling rings. The transducercontroller can supply energy (for example 0.1 microwatts-10 watts) pertransducer depending on frequency and method of delivery of the soundenergy, for example energy can be applied to alternating pairs oftransducers to create a phase controlled waveform ‘product.’ A twochannel waveform generator/phase controller and operably linked computerinterface are also shown.

FIG. 8 illustrates various embodiments of micro-machined oculartransducer arrays, showing phased array rings for placement over thecorneal limbus (FIG. 8A), fractional circumference arrays for use overportions of the corneal limbus (FIG. 8B), axial focused beam arrays fortopical corneal use (FIG. 8C), a section of a fresnel array from withcouplant slots (FIG. 8D), and an oblique view with couplant slots (FIG.8E).

FIG. 9 illustrates embodiments of a micro-machined annular ring arraywith Fresnel angle surfaces. Fresnel angles cut into individualtransducer faces. This design conserves couplant and redirects andfocuses energy at an oblique angle. The near field Fresnel zone isshortened. Signal phase delay for each transducer produces a combinedwave. FIG. 9A shows an array with a seven-ring fresnel design showing abeam from Fresnel ring number 1. FIG. 9B shows a semi-circulararrangement of such rings and the resulting wave product. Focused beamsare emitted from the entire fresnel array. FIG. 9C shows each ringreceiving one of seven phased-adjusted signals to individual transducerfaces so as to produce a single focused wave-form.

FIG. 10 depicts the manner in which waves propagate. FIG. 10Aillustrates how beams reinforce at nodal intersections with a 2×amplitude nodal intersection as waves propagate. FIG. 10B shows howphase and frequency modulation may be used to shift focus of target areaby manipulating signal from one transducer. FIG. 10C illustrates howtsunami waves from a topical axial transducer/array applied at thecornea decrease in wavelength and increase in amplitude at the shallowerdepths of the anterior eye. Modulated phase/frequency eliminates singletransducer hot spots that can damage the eye, and allow cavitationbubbles to build evenly throughout the target area. The zone of effectcan be moved without damaging or burning the cornea. The phased outputof transducers can be varied at ±90° to create wave cancellation,anti-nodes or reinforcement at nodes. With two transducers, the effectcan cancel or double the effective energy. With three or moretransducers, the target area can be more accurately defined. Frequencymodulation evens out the combined effect. For three or more transducersboth phase modulation and frequency modulation can be used to reduce hotspots.

FIG. 11A illustrates an exploded oblique schematic view of an embodimentof the gimbal mounted phased transducer array (ring or rotor) with4-axis controls as described for the in-clinic device (see Example 1). Amotor drive and transducer array rotors positioned at the cornea andcorneal limbus of the patient eye. The device has physician optics (forexample, to watch for clouding of vitreous or scarring of the cornea)and is operably linked to a computer controlled waveformgenerator/amplifier and real-time 2D/3D feedback imaging andpatient-specific therapy recordkeeping software. FIG. 11B shows the axisof adjustment for the gimbal mount which allow adjustments in/out,pitch, up/down and yaw right/left. FIG. 11C is a schematic of thepatient head positioned with the rotor in-line with the patient eyeusing a chin rest and forehead restraint.

FIG. 12 illustrates an embodiment of the phased transducer array rotor,in oblique side exploded view showing position adjustments and physicianoptics (A), rear view with an attached couplant skirt (B), and inschematic positioned at front of eye (C). The transducer phased arrayrotor 1 in this embodiment has three transducers 2 that can rotateperiodically or continuously, as desired. Couplant feeds 5 are part of acouplant dispensing skirt and the feeds automatically apply couplant gelto facilitate the transmission of sound energy from the transducers tothe surface of the eye. An axial transducer/array 3 delivers sonic andultrasonic frequencies axially to the corneal surface of the eye. Afour-axis positioning mechanism 4 is shown (rotor body in/out adjust,rotor arm radius adjust, corneal angle adjust and rotor arm in/outadjust) that adjusts the rotor to the size and sphericity of the eye.The four-axis positioning adjustments are separate from thecircumferential rotation 7 and rotor array rotation 8 of the device.Collimated target optics 6 allow the operator/physician to accuratelyalign the transducers to the desired area of the surface of the eye.Slots in the rotor body for configuration of the axial transducer/array3 with various types of transducers. Such a transducer array is built upout of transducers and fillers. An annular ring ‘set’ of transducers canbe built up as pictured in FIG. 12B, or a single axial transducer aspictured in FIG. 12A, or the same with three satellite smallertransducers for a total of four. Such configurations may be useful increating certain shapes of ‘tsunami waves’ for propagation through theanterior eye.

FIG. 13 illustrates an embodiment of an eyewear apparatus, in this casea pair of eyeglasses, in side view schematic with a radial transducerarray ring with and topical axial transducer at the front of the cornea(FIG. 13A), and as the device sits on the patient head (FIG. 13B). Theradial transducer array ring 1 has two or more transducers that deliversound energy radially to the exterior surface of the patient eye 8. Theaxial corneal transducer 2 delivers sound energy axially to the cornea9. Sound waves 11 are emitted from the ring array and tsunami waves 10are created. Illustrative support elements of the device are shownincluding a heavy duty eyeglasses frame 6, adjustable temple rests 7,and nose bridge rests 4. A positioning mechanism 3 having a suspensionsystem and 3-axis and eye spacing adjustment is also shown. Thepositioning mechanism positions the transducers on the surface of theeye and can be self-adjusting such that the position of the transducersis maintained when the eye moves.

FIG. 14 shows a left-eye anterior schematic of an embodiment of thetransducer array ring within the frame of the glaucoma glasses device.The device shows one of its two topical corneal transducer arrayscentered over the left eye with a topical axial transducer/array. Energyis applied to alternating pairs of transducers. The nose bridge rest,adjustable sinal nose rests, adjustable temple rests and heavy dutyframe position the glasses over the eyes.

FIG. 15 illustrates an exemplary glaucoma glasses transducer array. FIG.15A shows a close-up oblique view of an axial transducer/array withseveral transducers in the array ring covered by an arrayframework/cover. Patient operated surface engagement of the transducerarray brings the array to the surface of the eye. FIG. 15B shows theposition of the axial array prior to being located against the cornealsurface of the patient eye, in oblique cutaway schematic. The transducerarray contacts the eye at the corneal limbus and the positions of thetransducer faces on the corneal limbus. The relative anatomy of the eyeis shown (Schlemm's canal, TM, pupil and anterior chamber).

Contact lens technology has advanced far beyond correction of myopia(nearsightedness), hyperopia (farsightedness) and astigmatism, and nowcan be integrated with structures such as electronic circuits and usedfor numerous other applications (see FIGS. 16A-16D for examples of otheruses of contact lenses). FIG. 17A illustrates a rear view schematic ofan embodiment of a transparent battery contact lens transducer arraywith twenty-four transducers 1, for example, micro-machined or thin-filmtransducers, integrated into the contact lens. In this embodiment, eighttransducers are circular, and sixteen transducers are on the periphery.As described herein, the size, shape and configuration of transducers inthe transducer array can be varied according to the device or methodbeing used. The transducers are operably linked to an integrated powersource, here a layer containing a transparent battery 2 linked to thetransducers by battery electrodes 3, transducer driving circuits 4,circuit bus architecture 5 and system/power management circuits 7. Aphotocell array layer 6 facilitates the capture of solar energy to powerthe transducers. FIG. 17B shows a rear view oblique appearance of thetransparent battery contact lens transducer array. FIG. 17C shows aschematic of the resulting wave reinforcement intersection patternformed by four transducers energized along sections of the eye radius.

FIG. 18A shows a sectional depiction of an embodiment of a transparentbattery contact lens against the surface of the patient eye in obliqueschematic. The anatomy of the eye is shown (cornea, sclera, Schlemm'scanal, TM, pupil and lens). At the interface of the transparent batterycontact lens device is a couplant filled suction zone. FIG. 18Billustrates the phased function of the transducer tension ring inpromoting suction and positive grip to the patient eye while beingenergized. A high frequency set of transducers at the periphery of aplastic contact lens will have difficulty staying in contact with theeye. Bubbles could develop and the device could fall off. The transducertension ring is designed so that the entire circumference when energizedby transducers within this ring, expands and contracts, in concert withthe transducer array supplying treatment (Phase 1 and Phase 2). The neteffect will be like a lamprey eel, sucking the surface of the eye. Theprograms of the tension ring and the treatment transducers will bephased to ensure the lens stays in place.

FIG. 19A illustrates an exploded rear view of each layer of anembodiment of a transparent battery glaucoma contact lens transducer.The ‘appearance’ depiction combines the ‘look’ of the bi-polar outerfilm tear layer, and the thin film photocell layer beneath it. Somelayers may be tinted to diminish the ‘machine look’ of a photocell. Someembodiments may have an additional UV layer that protects the eye fromUV light (akin to sunglasses). The thin film photocell may be made ofcadmium telluride (CdTe), copper indium gallium diselenide (CIGS),amorphous thin-film silicon (a—Si, TF—Si), or any other suitablematerial. In some embodiments, a photovoltaic cell may have a diameterof around 12 millimeters. The transparent flexible battery layer maycontain any suitable transparent battery, for example, a transparentlithium ion battery or vanadium oxide graphene battery. The contact lensalso contains a transducer tension ring layer (see also FIG. 18B). Thetransducer and integrated circuit layer may contain PZT thin film highfrequency transducers (PMUTs), capacitive micro-machined ultrasonictransducers (CMUTs), or any other micro-machined or thin film transducertechnology. The transducers may be round, annular ring, chordate shapedor other shapes designed to produce an overlapping effect, andconvergent energies at the corneal limbus. The corneal contact layerinterfaces with the surface of the eye. FIG. 19B is a side viewsectional schematic of the layers assembled.

FIG. 20A shows an embodiment of a transparent battery contact lenstransducer array in exploded layer view from the rear, and FIG. 20Bshows the sections of each layer from the side. The contact lens layersare described in FIG. 19A.

FIG. 21A shows an exploded rear view of the layers of an embodiment ofthe wireless power transfer (WPT) contact lens transducer array (A) and,FIG. 21B shows an exploded section side-view. Here the ‘appearance’demonstrates the bi-polar tear layer has a certain opacity and tintdesigned to mask the appearance of the photocell layer. The othercontact lens layers are as described in FIG. 19A. An additional layer isshown containing the RF fractal antenna and UV filter layer over thepupil.

FIG. 22 illustrates two exemplary methods of powering the WPT contactlens, through electric induction (FIG. 22A) and by laser beam (FIG. 22B)using the wireless power transfer glasses device (see Example 4). Inanother example, energy is transferred from a coil in the eyeglasses toa coil in the contact lens by magnetic induction. In another example,energy is transferred from a laser beam in the eyeglass frame to aphotocell in a contact lens where an RF or IR feedback circuit insidethe contact lens calls for power. Safety shutoff control circuitry canbe included. Low level laser burst ‘tests’ the position of the eye. Ahigher power laser beam fires charging bursts but is interruptedimmediately if full power is not received by the contact lens.

FIG. 23 illustrates a sequence by which an embodiment of the laser WPTglasses transfers power to the transparent battery contact lens devicethat uses a laser beam to wirelessly transfer power to a contact lens.Depending on the location of the eye (FIG. 23A), the contact lens eitherconfirms a ‘safe’ response based a test pulse from the low level laser(FIG. 23B), the lens confirms with immediate feedback via IR/RF signalfrom the lens (FIG. 23C) or not, and if so, output of the charging laser(FIG. 23D) is made at a time when safe to the eye. If the feedbacksignal ends or indicates movement of the eye, charging terminates. FIG.23E illustrates in schematic the low level test and full charging levelsof the laser as well as the RF or infrared feedback system. FIG. 23Fdepicts the relative size and complexity of the charging glasses, with abattery pack worn on the person of the patient.

FIG. 24 illustrates an embodiment of the handheld transducer array unitwith three transducer array attachments and cutaway of a suspensionsystem (see Example 6). The handle of the device contains power andcontrol electronics. A mounting bracket and jack can be included for usewith the gimbal-mounted in-clinic system (see Example 1). A suspensionsystem and two spheroid surfaces can be used to adjust the phasedtransducer arrays.

FIG. 25 depicts an embodiment of the handheld transducer array attachedto the lower cost gimbal mounting device to deliver more preciseprograms of treatment than with the same system handheld. This devicecan be used to verify the treatability of a patient with frequencytherapy. It provides a quick application of sound energy to test atreatment program. It can be used to set up repeatable programs for useon other devices. The suspension applies power only when positivelyregistered against the eye. This device may be adapted for topical axialstimulation. The gimbal unit shown here is an attachment for theHandheld Transducer Array (Example 6) and is not necessarily the same asthe In-Clinic Device (Example 1).

FIG. 26 shows a transducer array with spheroid surfaces fitted to thecorneal limbus with three-axis suspension. FIG. 26A shows an embodimentof an array attachment for the handheld transducer array, with LFtransducers at the edge of the cornea and HF transducers over thecorneal sclera. The beveled double spheroid face matches the corneallimbus and a portion of the cornea. There are slots for heat dispersingcouplant. FIG. 26B shows a close-up of two examples of three-axissuspension with power interrupt. FIG. 26C shows wave intersectionsresulting from such a configuration.

FIG. 27 depicts an embodiment of the sonic frequency glaucoma glasses(see Example 7). FIG. 27A shows a side-view schematic with the locationand suspension of a HF Sonic Transducer against the exterior surface ofthe eyelid, an MF Sonic transducer at the temple and a transducerengagement lever. The device is supported and positioned by a heavy dutyframe, adjustable temple rests, adjustable cheekbone rests and nosebridge rests that sit atop the patient's nose. FIG. 27B shows the deviceas it would appear installed on patient head with the battery pack,control and signal generator operably linked to the glasses.

FIG. 28 depicts a top-view schematic of an embodiment of the sonicfrequency glaucoma glasses. The device is supported and positioned by aheavy duty frame, adjustable temple rests, adjustable cheekbone restsand nose bridge rests. HF Sonic transducers and MF Sonic transducers areadjusted and positioned at the patient's eyes using a suspension system.The patient controls engagement of the transducers usingpatient-operated engagement levers.

The Eye and Sound Energy

Eye Anatomy favorable to Sonic and Ultrasonic Treatment. The anatomy ofthe human eye and its drainage system are favorable to a frequency-basedtherapeutic approach to glaucoma. The Schlemm's canal and TM are 0.5millimeters below the surface of the corneal limbus, the border of thecornea and the sclera, or white portion of the eye. The TM is athree-layered meshwork is designed to slow flow of the intraocular fluidout of the eye. The fluid in the Schlemm's canal is directly adjacent tothe finest meshes of the TM. The outermost layers of the TM borders onthe Schlemm's canal and account for the most resistance to aqueous fluidoutflow. Clogged layers of the TM raise the resistance and increaseintraocular pressure in many forms of glaucoma. This geography indicatesthat the fouled regions of the TM are within acoustic stimulationdistance of the fluid in the Schlemm's canal.

In some embodiments of the devices disclosed herein, the introduction ofsonic and/or ultrasonic energy at an exterior surface of the eye, suchas in the region of the corneal limbus or at the cornea itself, near thecorneal limbus, or at the front of the cornea itself

Sound Energy and Health. In Ancient India sonotherapy has been used totreat all forms of disease. In general it is known that low frequenciespromote health. All forms of exercise are repeated rhythmic stressesplaced on different parts of the body, from the use of a trampoline (0.5Hz) to walking (1 Hz). Adult heartbeats (0.8-2.0 Hz) are known to sootheand relax small children. Drum beats (1-30 Hz) and singing (80-260 Hz)have demonstrable health effects on respiration and circulation whilelow frequencies relax muscles and tendons. Higher sonic and lowultrasonic frequencies encourage biological processes, by moving wasteand breaking up debris. Low frequency ultrasound accelerates healing ofbone fractures and encourages the circulation of lymph and blood.

Sound and Ultrasound

For the purposes of this disclosure, “sonic frequency,” as used herein,means any frequency within the range of from about 16 hertz to about 20kilohertz. For the purposes of this disclosure, “high sonic frequency,”as used herein, means any frequency within the range of from about 5kilohertz to about 20 kilohertz. For the purposes of this disclosure,“ultrasonic frequency,” as used herein, means any frequency within therange of from about 20 kilohertz to about 3 gigahertz. For the purposesof this disclosure, “low ultrasonic frequency”, as used herein, meansany frequency within the range of from about 20 kilohertz to about 200kilohertz. For the purposes of this disclosure, “high ultrasonicfrequency,” as used herein, means any frequency above 200 kilohertz.

Ultrasound. Ultrasound is like all sonic energy except that it occurs atfrequencies that are inaudible to human beings. The distinction betweeninfrasonic, sonic, and ultrasonic sound is based only on audible range.This is a species-dependent distinction. Dolphins and bats for instance,navigate with and locate prey using frequencies that are perfectlyaudible to themselves, but inaudible to human beings because they aretoo high in pitch.

Use in Medicine and Industry. Audible tones play a key role in thehealing of injured nerves and broken bones. Ultrasound speeds thehealing of bone, although it is not known why this occurs. Medicalultrasonography is currently used in all parts of the body. Cavitationultrasonics plays an important role for the destruction of kidney stonesin shock wave lithotripsy, as well as with phacoemulsification ofcataracts of the eye.

Intra-operative and laparoscopic ultrasound are used to cut and ablatediseased tissue. Focused ultrasound surgery (FUS) or high intensityfocused ultrasound (HIFU) are also gaining traction across the world,mainly in Europe, India and Canada, to treat such brain lesions, uterinefibroids and prostate cancers.

Numerous other uses for ultrasound are known in the art, for example,imaging systems, inspection of critical components and quality control.The mining and materials industry uses sonic and ultrasonic energies tovibrate, sort and blend materials of all kinds, liquids and solidsalike. Sonic energy is used in construction site to compact and moldconcrete. The food industry uses ultrasound to mix and emulsifyfoodstuffs such as mayonnaise and margarine. Vibration is used to moveheavy pieces of equipment over flat surfaces.

Physical Consequences of Vibration

Undulation. Any soft fluid filled body, such as living tissue, isaltered physically and dimensionally when affected by sonic orultrasonic vibration. Undulation is the process of physical ‘massage’ ofthe affected body when low frequency sonic vibration occurs. Thisprocess is similar to a rug being shaken, to dislodge the dirt withinits fibers. Undulation of the trabecular meshwork (for example, byburst, pulse or impact), may play an important role in dislodging debrisand allowing fluid to flow past the progressively tighter meshes to theSchlemm's canal.

Wavelength and amplitude are inversely proportional for a sound wavecarrying the same energy. Therefore when working with soft tissues likethe eye it is unlikely that anything but low energy waves will be usedin the sonic range, whereas total energies may rise safely as frequencyincreases. The devices and methods disclosed herein utilize thecharacter of both high and low frequencies, to directly address theproblems of clearing TM blockage, and expediting the flow of intraocularfluid.

Liquefaction. Liquefaction (from geology: ‘soil liquefaction’) is aprocess by which mixtures of solid particles behave like liquids whenagitated. Large buildings will sink into the earth when the ground isshaken enough, and empty hollow voids such as concrete sewers ordrainpipes may actually rise to the surface of the ground after aseismic event. In industry, when certain frequencies are applied tosieves and filters of almost any dimension, solid materials of therequisite size pass through easily. Most importantly liquids passthrough the most easily, and the passing of intraocular fluid out of theanterior eye is the primary objective in treating glaucoma. While thedebris clogging the TM of glaucoma patients is far from behaving likeperfect solid mixtures of aggregates such as sand or gravel, this debriswill have some solid constituents and some principles of liquefactionmay be applicable.

Cavitation. Cavitation is the formation of bubbles resulting from aphase change from liquid to gas, and back again to a liquid, and can beelicited by any sonic or ultrasonic frequency. Dolphins can swim so fastthat large and painful cavitation bubbles occur at the edges of theirflippers. This keeps them from using their highest speeds except whenabsolutely necessary. Tuna are able to swim at speeds that regularlycavitate seawater around their fins which are bony and have almost nonerve endings. Cavitation bubbles are major sources of noise andinefficiency around boat and submarine propellers, facts of physics thatcosts the marine industry hundreds of millions of dollars per year.

Cavitation occurs in the xylem of vascular plants when the pressure ofsap within the xylem falls so low that liquid water vaporizes locally.Cavitation causes coastal erosion when vapor pockets of incoming wavesare forced into cracks in the rocks. When the force of the wavescompresses the vapor pockets the bubble implodes, becoming liquid,giving off energy that blasts the rock apart.

Currently, sonoporation is being tested to see whether cavitation may beused to transfer large molecules into biological cells. Cavitation playsa role in the destruction of kidney stones in shock wave lithotripsy.Nitrogen cavitation is used in research to lyse cell membranes whileleaving organelles intact. Cavitation plays a role in non-thermal,non-invasive fractionation of tissue for treatment of a variety ofdiseases, and may play a role in high frequency focused ultrasound, athermal non-invasive focused treatment methodology for prostate cancerand blood clots. Ultrasound can be used to encourage bone formation inpost-surgical treatments.

Cavitation is the force behind ultrasonic cleaning in many industriestoday and is one of the physical consequences of vibration contemplatedby the devices and methods disclosed herein, for example, cavitatingliquid in the Schlemm's canal, within the TM, and also the anteriorchamber to break apart debris clogging the TM.

While cavitation is possible at any frequency, the use of sound andultrasound at sea level pressures in stationary fluids or within livingtissues, generally requires the use of ultrasonic frequencies. Whethercavitation occurs or not depends on a number of factors, including anincrease in the amplitude of the sonic or ultrasonic wave, a decrease inlocal ambient fluid pressure, an increase in the frequency of the sonicor ultrasonic wave, and the viscosity and makeup of the fluidsstimulated by transducer energy.

Thixotropy. The make-up of debris clogging the TM of a glaucoma patientmay vary depending on the type of the disease. It is believed that themajority of TM debris consists of a mixture of melanin granules andun-decomposed melanocytes or uveal cells as well as potentially othercell types and material from within the anatomy of the eye. It istherefore important to consider the physical properties of debrisclogging the TM. This debris can be considered to be thixotropic, i.e.,it demonstrates non-Newtonian properties when subjected to a shear forcesuch as acoustic energy, for example fluids, gels and mixtures that areviscous under static conditions but become less viscous when shaken,agitated or stressed (time-dependent viscosity).

Thixotropic mixtures respond to a threshold of shear stress by a change(lowering) of viscosity. A unique non-Newtonian property of thixotropicfluids is that this viscosity change occurs within a specified radius ofthe locus of shear energies. The fluids demonstrate an either/orbehavior, that can be utilized to confine the action of applied acousticstimulation. That is they suddenly experience a thixotropic decrease inviscosity due to applied shear forces, a change which occurs suddenlyand completely wherever those shear forces are in excess of a particularthreshold, and within a specific radius of the source of the shearforce, such as a transducer or transducer array. Ketchup is probably thebest known thixotropic mixture that responds to frequency, i.e.agitation, in order to be induced to flow more quickly.

If the debris in the TM is a thixotropic mixture of partly decomposedmelanocytes, melanin granules, uveal cells, etc. then when the correctshear force is reached, the coagulated debris will behave like a liquid.The action will occur within a definite radius of the energy source(Effective Area≤r_(n) for Energy I=P/4 πr_(n) ²) and the action occursevenly within precise radius of energy source if debris rheology isconsistent. The action will continue as long as shear energies areapplied and for some time afterwards as well. Shear forces need not beapplied with ultrasonic or cavitation frequencies, cavitation orsub-cavitation frequencies may alter the thixotropic properties of thedebris, and reduce energies needed to produce lower viscosities andhence lowering IOP. Thixotropic fluids will be the best absorbers ofcavitation energy, as their composite solids are fragmented further intofiner dimensions. The all or nothing behavior of thixotropic fluidsallows for a targeted approach. The radius of action of a shear stressfrom acoustic energy allows for a designed radius of action around atransducer array.

Ablation. Sonic energy can also be used to ablate, or destroy, livingtissue. Diseased tissues ablation refers to the use of focusedultrasound surgery (FUS) or high intensity focused ultrasound (HIFU) todestroy cancers, brain lesions, uterine fibroids and prostate cancers.In most of these treatments high energy high frequency focused beams ofultrasonic energy are used to heat and destroy diseased tissues. In theevent that cavitation approaches to cleaning the TM may not be forcefulenough to treat some patients, higher doses of energy might be requiredto ablate some of the finer meshes of the TM.

Intersecting Nodes. In some embodiments, the approaches to stimulatingthe TM disclosed herein utilize beams of acoustic energy applied bysingle or multiple transducers in contact with the eye. In the case ofmultiple transducer stimulation, the risk of burning or overheating anyportion of the eye can be mitigated, for example, through the use oflower level stimulation from two sources and using the overlappingenergies to coincide where the treatment is most needed. The nodes andanti-nodes of acoustic energy will reinforce or cancel each other out.The shifting of frequency and phase will further mix up exact loci ofthese nodes, evening out the effect over a specific area of the eye, andminimizing the risk of heat damage from energy produced by a singletransducer.

Focused Ultrasound. The transducers described herein may be designed tofocus their beams onto a localized area beneath the surface of the eye,and so to produce a cleaner ‘intersection’ of their energies. Inaddition, focused ultrasound beams may controlled and monitored atsub-corneal distances.

Tsunami Wave Migration of Acoustic Energy. A tsunami in the oceanoriginates when there is an up or down-thrust of the earth's crustsomewhere in the center of an ocean. This initiates a wave of energythat moves extremely rapidly away from the epicenter of the seismicevent toward the shores of the ocean. As this wave travels at extremelyhigh speeds through deep water, it begins to slow as shallower depthsare reached. Amplitude (wave height) increases but overall energies arediminished somewhat by attenuation of acoustic energies by the mediumand its surrounding confines. In other words, most of the energy of theearthquake is translated into violent wave activity at the perimeter ofits shores.

This phenomenon may explain the positive results of lowered IOP shown bymost patients who have undergone phacoemulsification (or phaco) of thecataract.

“Tsunami wave,” as used herein, describes waves migrating from theepicenter of a fluid filled basin that is shallower at the edges than atthe center. The anterior chamber of the eye is filled with fluid and hasmuch the same shape as a shallow sea. Topical stimulation of the corneahere will send a wave migrating outwards to the edges of the corneallimbus, and may be used to supplement or reinforce the energies suppliedtopically to that area. The transducer arrays described herein can bedesigned to create a wave in the center of the anterior eye; stimulationat that point is referred to herein as “topical axial transducerstimulation”.

Fourier Wave Transformation and Mixing. In some embodiments disclosedherein, frequencies can be mixed and applied through the sametransducer. This facilitates the application of a rolling ‘massage’ fromlower frequencies to the solid portions of the TM while at the same timestimulating fluid flow, phagocytosis, or cavitation cleaning of the TMwith higher frequencies applied by the same or nearby transducers. Insome embodiments, each frequency of sound originates with a variety ofphases, amplitudes (intensities) or points of origin.

Monotonic use of single-frequency sound offers the least attractivestrategy for treating glaucoma. Multiple frequencies mixed together andmultiple strategies for massaging the layers of TM, the streaming offluids out of the anterior eye, stimulation of phagocytosis,ultrasonically cleaning the TM using principles of cavitation, oroutright ablation of densely packed debris, are all strategies usingsound, where the requirement of frequency and energy are different. Themethods and devices disclosed herein provide an approach to the use ofacoustic energy that can be custom fitted to the specific needs ofindividual glaucoma patients.

Frequency Induced Phagocytosis. As most cells in the human body respondto vibration at some frequency, such as bone cells for bone repair, bonemarrow for immune system support, or muscle cells for the alleviation ofpain and stiffness, a regularly applied therapy of appropriatefrequencies can enhance the rate of phagocytosis (breakdown of cellulardebris) by the layers of the TM.

Real Time Imaging and Feedback. Whenever sound energy is introduced tothe body as a pulse or burst or a continuous wave, there is anopportunity to measure the reflected waves off various layers of tissuein the body and this can be done within the same transducer. This is thebasic concept behind ultrasonic imaging. In same embodiments, themethods and devices disclosed herein comprise a diagnostic and/orfeedback component, for example as part of the same device or transducerused to apply the therapeutic frequency stimulation, or as a separatecomponent. Such components may measure sound reflection (echoes) fromthe interior of the eye or may utilize sonography.

Safety Precautions for Medical Ultrasound

“To date researchers have not identified any adverse biological effectscaused by ultrasound even though three million babies born each yearhave had ultrasonic scans in utero.” (Diagnostic Ultrasound Safety, asummary of the technical report “Exposure Criteria for MedicalDiagnostic Ultrasound: Criteria Based on all Known Mechanisms” issued bythe National Council on Radiation Protection and Measurements, p. 1.)This being said, the introductions of energies that produce cavitationor other physical effects of fluids in an area such as Schlemm's canal,or the angle of the eye, must take into consideration and minimize ordiminish negative effects of such energy on living tissues. While itremains unclear whether there are any long-term effects of thediagnostic ultrasound in use today, scientists do know from laboratorystudies that ultrasound at high intensities creates immediate effects atthe time of exposure.

Hazards to fragile liquid filled cells are also somewhat unknown: “Whenultrasound passes through liquid it causes a sort of stirring actioncalled acoustic streaming. As the acoustic pressure of the ultrasoundincreases the flow of liquid speeds up. This stirring action, in theory,could occur in fluid filled parts of a patient's body, such as bloodvessels, the bladder, or amniotic sac [or Schlemm's canal]. Inexperiments with animals, when streaming of the liquid comes near asolid object, shearing can occur, and this can damage platelets and leadto abnormal blood clotting (thrombosis).” [Ibid, page 5]

Transducer Arrays

Sound energy can be delivered to the eye using one or more transducers.Non-limiting means for delivering sound energy include (i) directapplication of a single frequency; (ii) amplified mixing of differentfrequencies, where different waveforms are mixed and applied though thesame transducer; (iii) multiple transducer—standing wave nodalstimulation, which uses standing wave interference and targeted sonicstimulation utilizing nodes and anti-nodes; and (iv) multiple transduceroblique angle waveform mixing, which uses the eye anatomy to cause wavesfrom different sources to intersect.

The methods and devices of the present invention may contain arrays ofmultiple sonic and ultrasonic transducers of variable frequency, phaseand amplitude. The transducers may be arranged in any desiredconfiguration.

In some embodiments of the methods and devices disclosed herein, soundenergy is applied as radial topical stimulation, topical axialstimulation or a combination thereof. As used herein, “radial topicalstimulation” means stimulation at the surface of the eye in the vicinityof Schlemm's canal or the TM with an array of multiple transducers fordelivery of sound energy of variable frequency, phase and amplitude to aregion of the corneal limbus (see, for example, FIGS. 2, 3, 4 and 5). Asused herein, “topical axial stimulation” means application of soundenergy directly to the front of the cornea (see, for example, FIGS. 4,5, 8C, 12, 13, 14, 15, 27 and 28). Topical axial stimulation takesadvantage of the shape of the volume of fluid in the anterior chamberand utilizes a ‘tsunami wave’ (see FIGS. 4 and 5) to unleash soundenergy that will ripple to the perimeter of the anterior chamber and theTM. The physics of propagation through fluid dictates that amplitudesrise as the waves approach the shallow circumference of a fluid body(FIG. 10C). Topical axial stimulation can be applied to supplement theenergy applied topically via radial topical stimulation over the corneallimbus. Combined radial topical stimulation and axial cornealstimulation has the advantage of combining waveforms converging fromdifferent directions and uses multiple transducers located at differentpositions on the surface of the eye. In some embodiments, such a wavecan be a low frequency burst designed to clear the TM of particlesbroken up by much higher frequencies, or be an attenuated high frequencywave designed to supplement the power of radial topical stimulation.Preferably, the methods and devices disclosed herein will use the lowestwattages and sound frequencies possible, thus minimizing the amount ofenergy introduced to the eye, and confining the focus of the energy tothe areas targeted.

Examples of target areas of the eye to which treatments will be focusedare the TM and the Schlemm's canal (FIGS. 1, 2 and 3). These areas ofthe eye are very close (approximately 0.5 millimeters) below the surfaceof the corneal limbus, and the surface of the cornea, and the sclera, inthe area where they meet at the corneal angle is easily burned, and itis therefore necessary to introduce the energy to the surface at a levelto avoid burning (the “threshold energy” level), for example bypreventing two or more beams from sufficiently combining or focusing toproduce an undesirable result such as burning. The devices disclosedherein use various combinations of methods to ensure the subsurfaceenergy threshold in a confined area are enough to deliver an appropriatelevel of energy to treat the eye, but not to burn the eye. For example,this can be accomplished by focusing each individual transducer beamthrough the shaping of the transducer surface itself, coordinatingoutput frequency and phase of each transducer so that the net sum ofwave energies converges on the target area, using a specially machinedsurfaces on the transducers so as to introduce sound energy at anoblique angle to a surface of the eye, e.g., the corneal limbus, oraiming the beams so that there is a small area of overlap between themand adjusting threshold energy for the combined beams in this area sothat energies elsewhere avoid the negative side effects of burning.

In some embodiments, the methods and devices disclosed herein comprisetwo or more transducers acting in concert to apply a frequency product(FIGS. 6, 9 and 10). As used herein, a “frequency product” (or “FP”) isa combination of the same or different sonic or ultrasonic frequencies,with adjustments to phase, amplitude and duration. In some embodiments,combinations of sound energy can be learned and stored by the devicesdisclosed herein.

In some embodiments, the transducer arrays may vary in iterationaccording to one or more parameters such as cost requirements,lightness/size, distance between adjacent transducers, output energylevel and frequency or overall device design. For example, thetransducer arrays set into the glaucoma contact lens, described inExample 3 below, will preferably be designed so as to facilitate theincorporation of the transducers onto or into the contact lens, such astransducers constructed of thin-film or micro-machined transducers witha thickness of less than about 1 millimeter.

The shape and positioning of the transducers in the arrays may bedesigned as desired. In some embodiments, the transducers may have anydesirable shape, such as round, either circular, oval, or representing asection of a circle or an ellipse, square, rectangular, trapezoidal, orcrescent-shaped. In some embodiments, the transducers may be arranged orpositioned as an array, such as a linear array, annular array, gridarray or radial array. Arrangements of transducers may betwo-dimensional or three-dimensional.

In some embodiments, transducer thicknesses may be sized and tuned totheir natural resonant frequencies (half the wavelength) or be ofvariable frequency design as desired. The output to the transducers maybe pulsed as single or multiple waves, or continuous, and combinedsingle or multiple frequencies as desired, for example based on apatient's overall therapeutic program prescribed by a physician.

Surface and Design of Transducers and Transducer Arrays

Transducers may be constructed of different materials, and be of varioussizes, conducive to the design and desired use of a device. For example,micro-machined, or thin film transducers will be the technology ofchoice for the glaucoma contact lens described in Example 3, however theother devices may use a variety of transducer types.

The focusing of transducer energy via a phased array may occur through avariety of designs of the individual transducers themselves. The surfaceof a transducer in contact with the eye (the ‘feet’ or ‘contactsurfaces’ of the transducer) may have any desired shape, such as flat,concave or convex. In some embodiments, such surface is micro-machinedflat, concave or convex and may include a set of fresnel ridges (anglescut into the transducer face) (FIG. 9) to facilitate a directionality oftransducer energy. In some embodiments, arrays of transducers may haveindividual transducers set at angles different from each other tofacilitate the focusing of transducer energy (FIG. 3). For example, twoadjacent annular ring transducers may be angled so that their energiescoincide or intersect just below the surface of the eye.

Heat Dispersing Couplant and Dispensing Mechanisms

In some embodiments, a material (such as a liquid) that facilitates thetransmission of sound energy from the transducer into the eye (referredto as a couplant) is supplied to the interface of the face of thetransducer or transducer array and the surface of the eye. In someembodiments the couplant is biocompatible. In some embodiments, thecouplant is heat dispersing. The design and selection of the couplantmay be determined by factors such as the amount of heat energy to bedelivered, the solubility of the couplant by human tears, the ability ofthe couplant to be absorbed by tear ducts and broken down in lymph, andwhether the density of the couplant is suitable for introducing soundenergy into the cornea and/or corneal limbus of the eye.

Couplant may be applied or dispensed to the face of a transducer ortransducer manually (such as by hand prior to using a device).Alternatively, a device can be designed such that couplant isautomatically supplied as needed to the face of a transducer ortransducer array and/or to the surface of the eye that is contacted by atransducer or transducer array. This may be accomplished in variousiterations via a number of mechanisms (FIGS. 8D and 8E), for example, byextruding couplant from a dispensing mechanism on or in the device, suchas an opening or slots or holes located, for example, in a rotor oradjacent to a transducer or transducer array, or by means of a sprayonto a confined area of the eye. In some embodiments, a couplant mixturecan be produced by mixing a non-Newtonian fluid with artificial tears.Such a mixture would behave much as tears do except when subjected toshear stress at a very high frequency, at which time the couplantviscosity would increase due to its dilatant properties. Such a fluidcould be engineered to biodegrade in a safe and sanitary manner for theeye.

Power to Transducers and Transducer Arrays

The devices disclosed herein are powered electrically. Electric powermay be supplied by any source or combination of sources, including butnot limited to, electric mains, battery, capacitators or other powersupplies. In some embodiments, the power source is wireless. In someembodiments, the power source is rechargeable. For example, theIn-Clinic Device (see Example 1 and FIG. 11) and Hand-held PhysicianDevice (see Example 5 and FIG. 24) may be powered by electric mains anda separate power supply, and the Glaucoma Glasses (see Example 2 andFIGS. 13-15) and Sonic Frequency Glaucoma Glasses (see Example 7 andFIGS. 27-28) may be plugged to the electric mains, or powered by anoptional battery and power supply.

In some embodiments, the Transparent Battery Contact Lens (see Example 3and FIGS. 19-20) may be powered by an internal transparent or opaquebattery, storage capacitators, or by separate wireless power supplied bya special set of glasses worn by the user that conveys the power to thecontact lens either through magnetic field induction, by radiofrequency, or by a laser beam.

EXAMPLES

Illustrative embodiments of the methods and devices disclosed herein areprovided in the following non-limiting examples.

Example 1: In-Clinic Device

The In-Clinic Device, as described in this Example and illustrated inFIGS. 11 and 12, could be used as an initial assessment to determine thetreatability of a particular patient's glaucoma prior to prescription ofother treatment methods and devices. This device can be designed to havethe following features: immediate real time physical feedback,documentation of frequencies applied, where and how long (frequencyproducts), patient specific treatment records, repeatability oftreatments, variation of frequencies applied and mixes of frequenciesgenerated, precision of application and re-application of sound energy,and custom software to monitor treatment, analyze feedback and recordtreatment. It is expected that this device initially would require theuse of a physician, but later could be administrated by clinictechnicians under prescription from a physician.

An In-Clinic Device can have a transducer array fitted to a mountingblock with a surface matching the curvature of the corneal limbus of theeye (a topical radial transducer array). The transducer array can bemounted to a rotor, with a skirt designed to conserve and dispense heatdispersing couplant. This rotor-driven transducer array can be fitted toa gimbal unit to provide suspension and positive fitting of the arrayagainst the surface of the eye. The powering motor can be driven by adigital positioning system for sweeping the array around the radius ofthe corneal limbus according to any prescribed treatment program. Theunit can include an automatic shut-off whereby the patient eye isscanned visually by a camera or laser in the unit and when the eyestrays out of position relative to the transducer unit, power isimmediately cut. When the patient's eye moves back on target, so thatthe target circumference of the corneal limbus is directly beneath thetransducer array, treatment is resumed. In addition the rotor unitsupports the addition of a topical axial transducer array which isfitted to the front of the cornea (a topical axial transducer array).The transducer array can convey wave energy from the anterior center ofthe eye to the periphery of the anterior chamber and to the edges of theTM.

The In-Clinic Device can include a positive positioning patientheadrest, and collimated target optics to allow the patient to fixatethe eye on a target, and concurrently allow the physician to view intothe anterior chamber of the eye even when the topical radial transduceris in place and at work.

Both transducer arrays may be designed to produce a frequency product,that is a combined effect of focused, phased, and frequency modulatedfrequencies from multiple sources. The driving frequencies for eachtransducer in both arrays, can be produced by a control unit that iscontrolled by a computer, with software that allows the physician toprecisely determine which frequencies, what phase, what amplitudes, andwhat duration will be produced by each transducer in the array, andcombining that with what movements of the rotor and the portion of theeye is to be swept by the device.

The In-Clinic Device described in this Example, with its poweringcomputer and software, will allow for repeatable therapies, and accuratelogs of what frequency products were applied.

Example 2: Glaucoma Glasses

A modified version of the In-Clinic Device, called Glaucoma Glasses(illustrated in FIGS. 7, 13, 14 and 15), features similar but lighterweight transducers mounted in a gimbal suspension system mounted to aset of eyeglass frames, or helmet, with positive positioning withrespect to the patient's eyes. The glasses could run a programmedtreatment entered by the physician for a period of time. The glasses canachieve the objective of supplying lower cost treatment to the patientwithout the supervision of a physician. Patients could come into theclinic to use these glasses as directed, such as for a prescribed numberof hours per week. It is expected that such glasses could be designedand manufactured so that they could be used by the patient at home.

An important aspect of the Glaucoma Glasses is related to safety. Whilethe introduction of high frequencies to the eye are not likely to bepainful, there is the risk of discomfort to the patient. At all timesthe patient must be able to stop or cease the treatment process. Boththe programming and the design of the glasses will allow for predictableinterruptions.

The Glaucoma Glasses achieve the objective of supplying lower costtreatment to the patient without the supervision of a physician.Patients would come into the clinic to use Glaucoma Glasses for aprescribed number of hours per week and in time, when such machines canbe produced economically, they may be leased to patients for use athome.

Example 3: Transparent Battery Contact Lens

The Transparent Battery Contact Lens, worn by the patient, willregularly stimulate the corneal limbus of the eye with ultrasonicstimulation designed to loosen or cavitate TM debris and facilitate thedraining of fluid from the anterior eye. This device is a contact lensconstructed of multiple polymer layers. These layers can contain any orall of the following elements:

-   An exterior Bipolar Tear Layer to facilitate a layer of tears and    movement of the eyelid.-   A Photocell Layer, covering the iris of the wearer, and optionally    colored similar to the iris of the wearer. The edge of this layer    can be colored white to match the sclera of the wearer and the    transducer arrays located at the edge of the lens. The photocell    layer may contain a LED emitting infrared or other light radiation    for the purposes of communicating with the Wireless Power Transfer    (WPT) glasses (described in Example 4 below).-   An Induction Coil Layer if the device uses induction WPT.-   A Capacitor/Transparent Battery Layer—this layer is expected to make    up most of the thickness of the lens and is diopter adjusted to the    patient.-   A UV Filter Layer over the pupil region may be combined with one or    more of the other mentioned layers, as this will provide    sunglasses-like protection to the eye, and enable the user to be in    the presence of bright sunlight without compromising power from the    Photocell Layer.-   A Powering Circuit Layer containing the integrated circuitry for    powering the device, charging its internal batteries/capacitators    and for communicating with a WPT source of power.-   A Transducer Array Layer contains the micro-machined thin-film    transducers located on the periphery. This layer may contain a    dispensing mechanism, such as pouches or sacks, containing small    amounts of couplant that can be extruded to the eye surface via    transducer energy. This couplant may be composed of a catalyst and a    non-Newtonian fluid that responds to ultrasound stimulation by    increasing the viscosity of the tear layer.-   A Corneal Contact Layer is a bi-polar plastic layer that comes into    contact with the surface of the eye and is much the same composition    and material as other contact lenses known in the art.

The contact lens will supply ultrasonic stimulation and bursts ofcavitation level energy to discrete areas just above the TM on a regularbasis.

The contact lens can contain an operating system stored in on-board ROMchip and programmed by a Transparent Battery Contact Lens managementdevice operated by a physician or clinic. This can be used to set theprogram for the Transparent Battery Contact Lens, as prescribed by thephysician according to the type and severity of glaucoma suffered by thepatient. The program parameters, are fed from this device into thecontact lens, after which it can be worn and taken home by the patient.

The Transparent Battery Contact Lens can keep a record in its memory ofthe therapies administered to the patient. These are downloaded by theTransparent Battery Contact Lens management device upon return to theclinic. The Transparent Battery Contact Lens can be configured tocommunicate directly with an application in the patient's cellphone orPDA and so downloads therapy history to the clinic.

The Transparent Battery Contact Lens can have variations regarding useand sources of power. For example, the contact lens could use atransparent rechargeable battery and photocells for charging. Anotherexample uses laser WPT (see Example 4 below) to recharge the contactlens from a special set of glasses harboring a small laser beam andcontrol electronics housed in the eyeglass frame. Another example usesinduction WPT to induce regenerative power from a coil in the eyeglasslens or eyeglass frame to a coil located in the Transparent BatteryContact Lens. Both forms of WPT for recharging of the TransparentBattery can use an infrared (IR) or radio frequency (RF) feedbackcircuit or both. The RF circuit, though it may employ some level ofsignal encoding for security purposes, is potentially vulnerable to RFinterference from the environment, whereas an RF signal confirmed by aninfrared signal from a LED within the device could increase the safetyof the contact lens.

The Transparent Battery Contact Lens is powered by a transparentinternal battery. This battery can be rechargeable, such as by means ofa solar cell array which composes the portion of the contact lens thatcovers the iris of the patient, and can be colored to match the iriscolor of the patient. The charging electronics are located in thecircuit layer of the lens and handle the recharging of the device in amanner similar to other rechargeable solar cell powered devices. Thecircuitry interacts with the transducer array controls portion of thedevice to ensure that enough power is present before beginning a seriesof energy bursts to the transducer arrays.

The Transparent Battery Contact Lens is expected to use frequencyinduced phagocytosis and undulation massage of the TM as the primarytherapeutic method. The contact lens can use topical axial frequenciesfrom low to high ultrasonic. The total wattage at the cornea can bearound 1-40 watts with radial phased array frequencies of 20 kilohertzto 200 kilohertz/1 mircowatt to 5 watts at each transducer. For timedependent therapy, frequencies can be delivered as bursts for periods ofaround 0.1-30 seconds each.

Example 4: WPT Transparent Battery Contact Lens

Another iteration of contact lens device uses Wireless Power Transfer(WPT) to supply power to the Transparent Battery Contact Lens (FIG. 21).This device may be useful in areas without adequate sunlight, or forpatients requiring higher levels of therapeutic stimulation.

One embodiment of the WPT Transparent Battery Contact Lens uses laserwireless power transfer to recharge the device from a special set ofglasses harboring a tiny laser beam and control electronics beside eacheye in the eyeglass frame. A second embodiment uses induction WPT toinduce regenerative power from a coil in the eyeglass lens or eyeglassframe to a coil located in the Transparent Battery Contact Lens. Bothforms of WPT for recharging of the Transparent Battery Contact Lensrequire the use of an Infrared (IR) or radio frequency (RF) feedbackcircuit. A Fractal Antenna Layer to transmit and receive RF signals toand from WPT Glasses used for charging.

Some iterations could require both. The RF circuit, though it may employsome level of signal encoding for security purposes, is potentiallyvulnerable to RF interference from the environment, whereas an RF signalconfirmed by an Infrared signal from a LED within the device wouldincrease the safety of the device.

Example 5: Wireless Power Transfer (WPT) Glasses

As described in Example 4, Wireless Power Transfer (WPT) to a contactlens may be accomplished via a set of specially designed set of WPTglasses (FIGS. 22 and 23). This device facilitates inductive powercoupling or laser power coupling with the recharging circuits in theTransparent Battery Contact Lens. These glasses can be worn by thepatient during times of day when therapy is called for. The glasses mayor may not have corrective lenses for the patient's vision, allowing thepatient to work, read, drive or watch a movie during periods of therapy.The wirelessly powered contact lenses may combine any or all of thefeatures described herein for power transmission, generation, storage,or recharging.

For the induction rechargeable Transparent Battery Contact Lens, coilsin the WPT Glasses frames (or within the glass lenses themselves), passan alternating current which forms an oscillating magnetic field whichinduces an alternating current in the receiving coils of the TransparentBattery Contact Lens. This alternating current may be rectified and usedimmediately or stored by a capacitor, battery, or series of capacitatorsor batteries in the device. Whether energy is stored temporarily or useddirectly, it can be used to power the control circuits and transducerarrays of the Transparent Battery Contact Lens.

For the laser rechargeable Transparent Battery Contact Lens, anotheriteration of the WPT glasses uses a short burst from a low-power laserto beam energy to the photocell layer of the Transparent Battery ContactLens. Microbursts of laser energy at low levels occur regularly to testthe location of the charging photocell on the contact lens with respectto saccade movements of the eye. Positive feedback via RF or IR providesreal time position data to the charging device. The WPT Glasses ‘know’when the eye is in position to receive a charging burst of laser energy.If the feedback loop is compromised, paused, or stopped, no energy istransferred.

The human eye moves extremely quickly in bursts of movement termedsaccades. The peak angular speeds of the eye during a saccade reaches upto 900 degrees per second in humans. Saccades responding to anunexpected stimulus normally take about 200 milliseconds (ms) toinitiate, and then last from about 20-200 ms, depending on theiramplitude. 20-30 ms is typical in language reading. Because the eye canrapidly turn away from a fixed locus, the response time of the laserstart-and-stop electronics for the WPT Glasses must be equally rapid. Ifresponse times are short enough, and the charging laser is of anamplitude that would require a significant time to harm the eye, the eyemay be safeguarded by the use of a feedback circuit as described herein.Software for controlling the charging mechanism may be designed to learnthe patterns of saccade movement of the patient eye, boosting chargingefficiencies of the device. In other iterations, the movement of the eyemay be sensed by a photocell array in the lens. Once movement is sensed,power is terminated. The eye is protected by real time positive feedbackfrom the charging process, to prevent directing laser energy into theeye. The charging bursts may occur through the same or separate lasers,with either or both lasers projecting their beams in the same direction.If separate lasers, one laser may be dedicated to providing locationinformation to the device, for example the contact lens. Once the targetis ‘located’ and the photocell is appropriately angles, the charginglaser produces a burst of energy. If the charging burst commences, butfeedback is not received during the time of the charging burst, thecharging burst is terminated.

-   Laser sends out microburst of low-level laser energy.-   If it is received, the device sends repetitive coded signals on an    RF frequency and/or IR pulse back to the charging glasses.-   The charging glasses then send forth a burst of charging energy for    as long as the coded signals indicate that the eye is in position.-   The instant the RF feedback loop is interrupted the charging laser    switches off

In some embodiments, a light (for example, a low level LED light) may beincluded as part of the device that indicates to the user when the powerhas decreased below a recommended or acceptable level. The user can thenstare at fixed points without moving the eye, so as to speed up there-charging process of the device. Such feedback elements may alsocommunicate other device parameters to the user.

The laser source can be located within the eyeglass frame at the outsideof the eye, and the beam is directed at an oblique angle towards thesurface of the Transparent Battery Contact Lens where the photocellarray is located. The RF/IR feedback loop can continuously monitor thelocation of the device. Bursts of power may be in the order of 1-200milliseconds. Bursts for low bursts for purpose of feedback on positionmonitoring of the device are much shorter and at a tiny fraction of theenergy of the main charging laser.

Example 6: Physician Handheld Transducer Array

A transducer array as described above for the In-Clinic Device couldalso be fashioned into a hand-held device (FIGS. 24, 25 and 26). Thehandheld device would allow a physician to directly apply sound energystimulation to a portion of the glaucoma patient's eye. Similar to theIn-Clinic Device, the Physician Handheld Transducer Array allows theremoval and replacement of a variety of transducer array heads. Thereare three illustrative transducer arrays that may be fitted to thisdevice, depending on which area of the eye the array will contact whenfitted to the eye, for example, arrays that have a spheroid surface forfitting to the corneal sclera (the white portion of the eye), arraysthat have a complex dual spheroid surface for fitting to the corneallimbus (the junction of the cornea with the white of the eye), or arraysthat have a spheroid surface fitted to the front of the cornea. ThePhysician Handheld Transducer Array combines a single interchangeabletransducer array with a handheld unit. It can be designed to receivepower and control from the same attached PC with dedicated software asthe In-Clinic Device, except that there is no rotor, or automaticrotation machinery. The unit is designed to be handheld, or optionallymounted to the gimbal system for rotation by the physician.

Example 7: Sonic Frequency Glaucoma Glasses

As illustrated in FIGS. 27 and 28, two high sonic frequency transducersstimulate the patient's closed eyelids, while a pair of larger MF Sonictransducers apply debris clearing energy from the patient temples. Thisdevice would employ frequency induced phagocytosis and liquefaction. Thesonic frequencies used in this Example are designated “HF Sonic” to meanhigh-pitched sonic frequencies, which are audible, as opposed to “HF”which stands for high frequency ultrasonic frequencies. “MF Sonic” meansmid-range audible energies.

Reference throughout this specification to “one embodiment,” “someembodiments,” “one or more embodiments” or “an embodiment” means that aparticular feature, structure, material, or characteristic described inconnection with the embodiment is included in at least one embodiment ofthe invention. Thus, the appearances of the phrases such as “in one ormore embodiments,” “in certain embodiments,” “in one embodiment” or “inan embodiment” in various places throughout this specification are notnecessarily referring to the same embodiment of the invention.Furthermore, the particular features, structures, materials, orcharacteristics may be combined in any suitable manner in one or moreembodiments.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It will be apparent to those skilled in the art thatvarious modifications and variations can be made to the method andapparatus of the present invention without departing from the spirit andscope of the invention. Thus, it is intended that the present inventioninclude modifications and variations that are within the scope of theappended claims and their equivalents.

What is claimed is:
 1. A method for treating glaucoma, comprising:providing a portable contact lens having a plurality of sound generatingtransducers, the portable contact lens configured to contact a mammalianeye; and energizing the plurality of sound generating transducers toapply therapeutic bursts of ultrasonic energy to a portion of themammalian eye, the portion selected from the group consisting ofSchlemm's canal, trabecular network and a combination of Schlemm's canaland the trabecular network, each transducer of said plurality of soundgenerating transducers producing the therapeutic burst of ultrasonicenergy with a power of between 1 microwatt and 5 watts and a duration ofbetween 0.1 second and 5 seconds to destroy debris clogging thetrabecular network and promote an outflow of intraocular fluid therebylowering intraocular pressure.
 2. The method of claim 1 wherein theportable contact lens is selected to include: a transducer and circuitlayer having the plurality of transducers electrically interconnected toa system power circuit via a circuit bus wherein the plurality oftransducers, system power circuit and circuit bus are all supported bythe transducer and circuit layer; a battery layer abutting thetransducer and circuit layer supporting a rechargeable battery, therechargeable battery electrically interconnected to both the pluralityof transducers and the system power circuit; and a thin-film photocelllayer supporting photocells that are electrically interconnected to therechargeable battery, wherein a portion of each of the respectivetransducer and circuit layer, the battery layer and the thin-filmphotocell layer that overlies a pupil are optically transparent.
 3. Themethod of claim 2 wherein each transducer of the plurality oftransducers is independently selected from the group consisting of PZT(lead-zirconium titanate) thin film high frequency transducer PMUT(piezoelectric micromachined ultrasonic transducers), capacitivemicromachined ultrasonic transducers (CMUT) and other micromachined orthin film technology.
 4. The method of claim 3 wherein each transducerof the plurality of transducers generates bursts having a frequency ofbetween 20 kHz and 200 kHz.
 5. The method of claim 4 wherein thetreatment includes the portable contact lens contacting the mammalianeye during waking hours and each said transducer generating 10 bursts ofultrasonic power per day.
 6. The method of claim 4 wherein a duration ofthe burst of ultrasonic power is four seconds and each transducer ispowered for 40 seconds per day.